Learner 10
Registered
Hi All,
I am new to medical device Regulatory Affairs and trying to get to grips with Quality management System Significant Change Notifications. I have referred to the NBOG for Best practices for reporting Design and Quality Management system changes.
My change is in relation to an outsourced warehouse and whether I need to submit a significant change notice to the notified body to add storage of finished products to an already existing outsourced warehouse.
Just wondering if anyone can shed any light
Thanks!
I am new to medical device Regulatory Affairs and trying to get to grips with Quality management System Significant Change Notifications. I have referred to the NBOG for Best practices for reporting Design and Quality Management system changes.
My change is in relation to an outsourced warehouse and whether I need to submit a significant change notice to the notified body to add storage of finished products to an already existing outsourced warehouse.
Just wondering if anyone can shed any light
Thanks!